BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIKE COUPLER

    MDR report key: 18911824 · Received March 15, 2024

    Report

    Report Number
    18911824
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    January 9, 2024
    Report Date
    January 17, 2024
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    KJG
    UDI-DI
    10816203020021
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A CELLULAR TRANSPLANT A ¿T-CONNECTOR/SPIKE ADAPTER¿ WAS BEING USED AND WHILE TRYING TO CHANGE OUT THE BAG OF CELLS, ONE OF THE SPIKES BROKE OFF INTO THE CELL BAG. A NEW T-CONNECTOR WAS USED AND DURING CELLULAR INFUSION TAKEDOWN THE SAME THING HAPPENED WHERE ONE OF THE SPIKES BROKE OFF INTO THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411289 SPIKE COUPLER TUBE, TISSUE CULTURE KJG ORIGEN BIOMEDICAL, INC. 2S-P20 10816203020021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown